Hyperthermia, system, method, and components

ABSTRACT

An IV pole mountable, therapeutic infusate processing device is incorporated into a hypothermia system to receive therapeutic fluid(s), such as normal saline, peritioneal dialysis solution, or other crystalloid solution, to heat such therapeutic fluid(s) a few degrees centigrade above normal body temperature and to direct the resulting heated infusate to and through a selected anatomical portion of a patients body to raise the temperature of that body portion so as to affect any cancerous or other tumors that may be located therein. The processing device is provided with touch screen controls and visual indicators to facilitate its proper use; while the system further includes temperature and pressure sensors to monitor the hyperthermia processing to insure patient safety.

BACKGROUND OF THE INVENTION

Field of Application

This invention relates to the treatment of diseases by raising bodytemperature; and more particularly to raising the temperature of aspecific anatomical portion or portions of a body.

Description of the Prior Art

Hyperthermia as a treatment of tumors has been carefully studied andapplied. There appear to have been multiple reports of tumor regressioncoincident with febrile episodes. Some analysis revealed that bodytemperatures greater than 41 degree C. are ordinarily needed to inducetumor necrosis (tumor death). Although, there are multiple methods ofinducing hyperthermia by either direct skin contact or radiant heating,many physicians have favored an extracorporeal heat exchange (blood)circuit to raise patient body temperatures. Some patients have beenmaintained at 41.5 degrees to 42 degrees C. (rectal temperature) forthree to four hours without severe cardiovascular compromise; however,others have suffered elevation of serum transaminases and bilirubin whenkept at such temperatures for greater than 10 to 40 minutes. There havealso been Instances of neurological damage in association with serumhypophosphatemia, although no significant problems occurred oncephosphate levels were maintained. Death may also occur for patientsreceiving hyperthermia at 41 degree to 42 degree C. for 1½ to hours,presumably from massive liver tumor necrosis.

U.S. Pat. No. 2,886,771 to Vincent; U.S. Pat. No. 3,482,575 to Claff;U.S. Pat. No. 4,061,141 to Hyden, U.S. Pat. No. 4,191,182 to Popovich;U.S. Pat. No. 4,321,918 to Clark; U.S. Pat. No. 4,322,275 to Jain; U.S.Pat. No. 4,381,004 to Babb; U.S. Pat. No. 4,479,798 to Parks; U.S. Pat.No. 4,540,401 to Marten; U.S. Pat. No. 4,563,170 to Aigner; U.S. Pat.No. 4,576,143 to Clark and U.S. Pat. No. 4,692,188 to Troutner et al.;all relate to methods for the extracorporeal treatment of blood forcancers, viruses and parasites. Tumors are vulnerable to heat and thegoal of hyperthermic treatment therapy is to achieve cytotoxictemperatures in the tumor for a sufficient length of time withoutdamaging the surrounding normal tissue. The rate at which blood flowsthrough any given area of tissue determines the amount of heat that maybe carried away and therefore is a major determinant of the temperaturerise in that tissue. In normal tissue, heat causes vasodilatation. In atumor, the microvasculature is made up of an overabundance of capillarybeds, which are unable to dilate. Blood flow through the area is thusmore sluggish and commensurately unable to dissipate heat applied to thearea. The inability to respond to heat by dilation, as normalvasculature would, also subjects the tumor to hypoxia, anaerobicmetabolism and local acidosis, and these conditions in turn make thetumor tissue more vulnerable to thermal injury.

U.S. Pat. Nos. 5,354,277 and 5,476,444 are directed to methods andapparatus for effecting whole-body hyperthermia: however, the equipmentand procedures disclosed appear to suffer from relatively difficulttemperature controls for the fluid handling systems; possible risk ofcontamination; and possible difficulty to optimize the fluid handlingsystem for a particular indication.

Some physicians, on the other hand, favor heating only body cavities,such as the peritoneal, and/or chest, cavity with heated fluids tocreate hyperthermia of the respective tissue surfaces within the cavity.U.S. Pat. Nos. 6,579,496 and 6,827,898 appear to be directed to not onlybody hyperthermia through extracorporal blood heating with circulationof the heated blood through a patient; but also to heating a therapeuticfluid for passage through a regional anatomical area of the body. Thesepatents describe systems which kluge together hospital availableequipment such as hemodialysis machines with tubular heat exchangers andhigh flow positive displacement pumps. The resulting equipment appearsto be large and cumbersome, for the task and for the relatively tighthospital quarters for the patient. In addition, the heating oftherapeutic fluids, that are to pass through the patient's body, and thepassing of such fluids through the patient's body, at such elevatedtemperatures and flow rates, could be damaging to the patient and evenmore detrimental to the patient then the disease to be treated.

SUMMARY OF THE INVENTION

It is therefore an object of this invention to provide new and novelsystems for implementing hyperthermia.

It is another object of this invention to provide new and novel methodsfor implementing hyperthermia.

It is yet another object of this invention to provide new and novelapparatus for incorporation into hyperthermia implementation systems andmethods.

It is yet still another object of this invention to provide new andnovel hyperthermia systems to be used in therapeutic procedures in whichfluid is held at a few degrees centigrade above normothermic to bepumped into a body cavity and continuously withdrawn and reheated.

It is yet still another object of this invention to provide new andnovel hyperthermia systems and methods, to be used in therapeuticprocedures, in which the combination of temperature and fluid flow ratefor therapeutic fluid(s) used thereby are optimized and may be operationset.

It is yet still another object of this invention to provide new andnovel hyperthermia systems and methods, to be used in therapeuticprocedures, in which the combination of temperature and fluid flow ratefor therapeutic fluid(s) are optimized, by heating the therapeutic fluidto only a few degrees C., above normothermic, and, by circulating,withdrawing and re-circulating such fluid, to and through a body cavity,at a flow rate commensurate with the selected temperature; to provide anefficient hyperthermia system and method which is relatively effectiveand safe for the patient, and may be operator set.

It is yet still another object of this invention to provide new andnovel hyperthermia systems to be used in therapeutic procedures in whichtherapeutic fluid is held at a few degrees centigrade above normothermicto be pumped into a body cavity at a relatively safe flow rate whilebeing continuously withdrawn and reheated.

It is yet still another object of this invention to provide a new andnovel system and method for heating infusion fluids in which such fluidsare heated to a predetermined temperature during slack time betweeninfusion demands, and held as so heated in anticipation of future use.

It is yet still another object of this invention to provide new andnovel hyperthermia systems to be used in therapeutic procedures in whichthe infusion fluid is heated to a predetermined temperature during slacktime, between infusion demands, and held as so heated in anticipation offuture use.

It is yet still another object of this invention to provide new andnovel hyperthermia systems to be used in therapeutic procedures in whichthe infusion fluid is heated to a predetermined temperature during slacktime, between infusion demands and without intervention of an operator,and held as so heated in anticipation of future use.

It is yet still another object of this invention to provide new andnovel and disposable fluid administration sets which are constructed ofmaterials that can be sterilized and made pyrogen free by conventionalmethods and so that single use thereof is economically feasible.

It is yet still another object of this invention to provide new andnovel disposable fluid administration sets which are constructed ofmaterials that are free of latex and DEHP.

Other objects of this invention will hereinafter become obvious from thefollowing description of the preferred embodiments of this invention.

The instant hyperthermia system and method utilizes therapeutic fluidheated to only a few degrees above normothermic and which is pumped at areasonable flow rate. The system monitors fluid temperature, linepressure, and air in the fluid path to ensure safe operation and alarmsat all unsafe conditions. An override circuit prevents unsafe operationin case of system computer failure. A touch screen displays flow rate,total fluid pumped, output temperature, patient temperature (2 locationsspecified by the physician), line pressure, alarm and status messagesand proper procedures to proceed safely after an alarm situation. Keysappropriate to a particular point in the operation are displayed on thetouch screen.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a diagram of the hyperthermia system and method, incorporatingand embodying the principals of and the instant invention, shown with arepresentation of a patient's body.

FIG. 2 is a perspective elevation view of a therapeutic fluid processingdevice incorporating the instant invention and which includes a fluidheater and pump, shown with a disposable IV set, also incorporating theinstant invention, positioned for co-action with the mechanisms of thefluid processing device, all as mounted upon an IV pole;

FIG. 3 is a is a front elevation view of the fluid processing device ofFIG. 2 with its access door open to better show details of some of themechanisms there-within;

FIG. 4 is a perspective elevation view of the fluid processing device ofFIGS. 2 & 3 showing same being mounted to the IV pole with its accessdoor closed;

FIG. 5 is a perspective elevation view of the fluid processing device ofFIGS. 2-4 showing same being mounted to the IV pole;

FIG. 6 is a perspective elevation view of the disposable set of FIG. 2,incorporating the instant invention;

FIG. 7 is a perspective elevation view of the fluid showing a portion ofthe disposable set of FIGS. 2 and 6, installed within the fluidprocessing device of FIGS. 2-5, enlarged somewhat, to better show detailthereof.

FIG. 8 is a face view of the control panel display/monitor for the fluidprocessing device of FIGS. 2-5;

FIG. 9 is a perspective view of a reservoir holding bracket for mountingthe two fluid reservoirs of the disposable set of FIG. 6, to the IVpole, as shown in FIG. 2.

FIG. 10 is a partial elevation view inside the fluid processing deviceof FIGS. 2-5 and 7, showing the mounting there within of the heatexchanger of the disposable set of FIG. 6;

FIG. 11 is a partial elevation view inside the fluid processing deviceof FIGS. 2-5 and 7, showing the mounting there within of the interlockof the disposable set of FIG. 6 into the fluid out detector of the fluidprocessing device of FIGS. 2-5 and 7; and,

FIG. 12 is a partial elevation view inside the fluid processing deviceof FIGS. 2-5 and 7, showing the mounting there within of the pressurechamber of the disposable set of FIG. 6 into a pressure chamber well ofthe fluid processing device of FIGS. 2-5 and 7.

DESCRIPTION OF THE INVENTIVE EMBODIMENTS

With reference to FIGS. 1 & 2, there is generally shown at 30 ahyperthermia system, incorporating the instant invention. Therapeuticinfusion fluid(s) 32, and/or 34, are provided to system 30 from eitherone or more conventionally available IV type bags 36, 38. Fluid tubularlines 40 and “Y” connectors 42, of section 44 of an infusion fluiddisposable set 46, direct infusion fluid 32, 34 to reservoirs 50, 52, ofthe infusion fluid disposable set 46; for storage and further use aswill be described in greater detail hereinafter. Additional tubularfluid lines 60 and “Y” connectors 62, of section 64 of disposable set46, direct fluid(s) 32, 34 from reservoirs 50, 52 to and through atherapeutic fluid processing device 70. Therapeutic fluid 32, 34 afterbeing processed by device 70 is directed into a patient tubular fluidfeed line 80 (FIG. 1) to a respective anatomical portion 82 of apatient's body 84, and then, from that anatomical portion 82, by apatient tubular fluid return line 86 back to and through fluid lines 40and “Y” connectors 42 to reservoirs 50 and or 52. Fluid feed line 80,and fluid return line 86 together constitute a patient's line 88 (FIGS.2,6) that may be provided as two separate lines or as a single patientline 88 of predetermined length to be divided into feed line 80 andreturn line 86 as it is required and as will be hearing after explainedin grater detail.

Therapeutic fluid processing device 70 is of a weight, size andconfiguration that permit it to be mounted to, and utilized when,carried by a conventional IV pole 90 (FIGS. 2, 4 & 5) whether, or not,such IV pole is provided with a wheel base 92 as shown in FIG. 2. Device70 may just as easily be utilized when positioned on a substantiallyhorizontal surface such as a table, cabinet or the like as long as it isin proximity to the patient that is to undergo the intended procedure.

A vacuum trap 94 (FIGS. 1,2 and 6) is connected by a suitable vacuumline 96 (FIG. 1) to the vacuum regulator/wall suction (not shown) of thelocation (hospital, etc.) where patient 84 is to be treated and by avacuum line 98 (FIGS. 1,2 and 6) and “Y” to the top of reservoirs 50,52.

Device 70 includes a housing 100 (FIGS. 2-5); which includes a top 102,a bottom 104, a left side 106, a right side 108 and a back 109 (FIG. 5)which together form a housing body 110 and define there within acomponent space 112 (FIG. 3). An access door 120, hingedly connected tobody portion 110 as at 122 (FIGS. 3 & 4), permits access into componentspace 112 and to mechanisms and components housed and mounted withinhousing 100; as will be explained in greater detail herein after.Windows 124, 126, and 128, formed through access door 120, are coveredwith “PLEXIGLAS”, or similar transparent material, to facilitateobservance of the processing taking place by device 70.

A conventionally available magnetic induction heater 140 (FIGS. 2 and3), securely positioned within component space 112 of housing body 110,includes a heating ring 142 (FIG. 3) that projects through a componentwall 144 (FIGS. 2 & 3) fixedly and vertically positioned within housingbody 110. Suitable and conventional electric power is provided totherapeutic fluid processing device 70, through a power cord (not shown)that is to be connected to an electric outlet (not shown), and therefrom to heater 140. A substantially conventional computer 146 (FIG. 3),also fixedly positioned within housing body 110, along with its controland operating software and/or hardware 148, also receives power throughthe power cord (not shown). Device 70 may also be provided with back-upbatteries (not shown) (rechargeable or otherwise) also housed withinhousing body 110 and suitably connected to the components and mechanismsthere within that require electric power to operate. A conventionalroller-type peristaltic pump 160, also positioned within housing body110 and with a portion 162 of pump 160 extending out through wall 144,also receives suitable electric power through the power cord (not shown)and operates under control of computer 146 and its associatedsoftware/hardware 148 as will be explained in greater detail hereinafter.

Positioning grooves 170, 172 (FIG. 3) are formed in the surface ofcomponent wall 144, of housing 110, to receive specific sections oftubular fluid lines 60 (FIG. 2) of section 64 of disposable set 46.Positioning guidelines 174, 176 are also provided on wall 144 tofacilitate positioning and placement of relatively narrower tubularfluid lines as will be further explained herein after. A temperatureprobe 180 (FIGS. 2 & 3) is mounted on wall 144 proximate a fluid entry182 (FIG. 3) to heater 140 and another temperature probe 184 (FIGS. 2 &3) is mounted on wall 144 at a fluid exit 186 (FIG. 3) from heater 140.Temperature probes 180, 184 are suitably connected to power and computer146, and its software/hardware, and they are of the infrared type butother types of temperature probes may just as well be so mounted andused as will be further explained herein after. A substantiallysemi-cylindrical pressure chamber well 188, formed in wall 144, receivesa pressure transducer 190, which is also mounted to wall 144 of housing100 proximate an air detector 192. A diversion valve 194 is also mountedon wall 144 between fluid line positioning grooves 174, 176. A fluid outdetector 196 is carried by wall 144 proximate a fluid entry 198 intodevice 70 and its fluid pump 160.

Access door 120 is formed with a door panel 210. An inner surface 212(FIG. 3) of door panel mounts a ferrite, or iron core, magnetic plate214 with a lip 216 extending out there from, for co-action with heaterring 142 of magnetic induction heater 140 and heat exchanger rings 218(FIGS. 2 & 6) of disposable set 46; as will be hereinafter explained ingreater detail. A door latch support 220 (FIGS. 3 & 4) extends frompanel 210 to an edge 222 of access door 120 and supports a door latch224 (FIG. 3) that co-operates with a door catch 226 that is carried bywall component 144. A pressure chamber support 228 (FIGS. 3 & 4) extendsup from door latch support 220 for co-action with a pressure chamber 230(FIG. 2) of disposable set 46 when pressure chamber 230 is positioned inpressure chamber well 188 (FIG. 3) proximate pressure transducer 190, aswill be hereinafter explained in greater detail. A fluid tube holder 232(FIGS. 3 & 4) extends inwardly (in the plane of the access door) fromedge 222 of access door 120.

A computer monitor touch screen or display 240 (FIGS. 2-5, 7 & 8) isprovided atop housing 100 to provide data output from computer 146 tothe operator concerning operation of the therapeutic fluid processingdevice 70 and for the operator to provide instructions to computer 146,by way of touch screen 240 to control operation of device 70 and system30. Device 70 is also provided with conventional phone-type input jacks246 and 248 (FIG. 5) for connection, through conventional cables (notshown) to external temperature probes (not shown) if needed and atlocations of the patient's body under physician instructions.

A carry handle 260 (FIGS. 2-5) is provided for device 70. Housing 100 ofdevice 70 is further formed with an IV pole indent space 262 (FIGS. 2 &5) having an IV pole entry space 264 of a size and configuration toreceive IV pole 90. A device clamp 266 (FIG. 5) is movably mountedwithin body 110 of housing 100. Clamp 266 includes a clamp end 268 thatis either: extendable from housing 100 into space 264 to co-act with IVpole 90 to clamp device 70 to IV pole 90 or retractable from space 264to release device 70 from IV pole 90 and permit removal there-from. Adevice clamp-operating handle 270 is pivotally mounted at 272 formovement in a counterclockwise direction from position “A” to position“B” to project clamp end 268 into space 264 for co-action with an IVpole 90 when device 70 is disposed to be secured to an IV pole 90.Pivoting of operating handle 270 from its position “B”, clockwise aboutpivot 272, to position, “A” retracts clamp end 268 and releases device70 from an IV Pole 90. A device support clamp 274, split at 276 andpivoted together at 278 to facilitate being secured to IV pole 90 tofurther support device 70 when secured onto IV pole 90, is provided witha set screw 280 to facilitate securing clamp 274 in place as will befurther described herein-after. A protective washer 282, open at 284 issized and configured to snap around IV pole 90, to further facilitatesecuring device 70 in place on IV pole 90. Support clamp 274 andprotective washer 282 together provide a support assembly 286 tofacilitate positioning device 70 on IV pole 90. An interlock block 290(FIGS. 2 & 3) is also positioned in device 70. An on/off switch 292(FIG. 2) is provided for device 70.

As set forth herein-above fluid disposable set 46 (FIGS. 2 and 6)includes a pair of reservoirs 50, 52 to be connected to IV bags 36, 38(FIG. 2), when so required and when mounted on IV pole 90, to receivefluid there-from. The interconnections of reservoirs 50, 52 and IV bags36, 38 (FIGS. 2 & 6) is accomplished through fluid lines 40 and “Y”connectors 42 as needed and in conventional manner. Conventional bagspikes 300 (FIG. 6) and bag clamps 302, as well as connectors 306 andquick connectors 308 may be utilized in setting up disposable set 46.For description purposes disposable set 46 has been divided into twosections with section 44 extending from fluid bags 36, 38 to reservoirs50, 52 and set 64, with its fluid lines 60 and “Y” connectors 62extending from reservoirs 50, 52 to and through fluid processing device70. Check vales 309 and roller type clamps 310, as well as other clampsand connectors, similar to those of section 44 may be utilized, inconventional manner when setting up disposable set 46. Also included aspart of disposable set 46 is a set of heat exchanger rings 320 andpressure chamber 230; as well as patient line to be divided, as needed,into fluid supply line 80 with its vent cap 322 (FIGS. 2 & 7) and fluidreturn line 86 (FIGS. 1 & 6). A dual reservoir holder 330 (FIGS. 2 & 8)includes reservoir receivers 332 and 334 that are sized and configuredto receive, position and hold reservoirs 50, 52, respectively. Areservoir holder securing clamp 336 (FIG. 8), secured to both receivers332 and 334, is formed with an opening 338 sized and configured to fitaround IV pole 90, A thumb-type screw 340 is threaded through clamp 336to facilitate securing holder 330 to IV pole 90. Receivers 332, 334 areformed with openings 342, 344 respectively that permit a sufficientdegree of movement of holders 332, 334 to snugly receive and holdreservoirs 50 and 52. (FIGS. 2 and 6). While holder 320 has been shownwith two receivers 332, 334 it may also be fabricated with a singlereservoir receiver as well as being fabricated with reservoirreceiver(s) of a size and configuration for the quantity of fluid to beheld by the respective reservoir.

When a physician for a patient prescribes hyperthermia, 86 (FIG. 1) thepatient 86 is usually placed in a proper atmosphere, such as a “sterilefield” in an operating room. According to the instant hyperthermiasystem and procedure an IV pole 90 (FIG. 2), a therapeutic fluidprocessing device 70 and a disposable set 46 are made available. IV Pole90, preferably, should be of the 5-wheel type with a maximum diameter1¼″. Support Assembly 286 (FIG. 5) is, preferably, secured approximately30″ above wheelbase 92 of IV pole 90 by installing support clamp 276, inits open position as shown in FIG. 5, around IV pole 90, closing supportclamp 276 and tightening it in place using setscrew 280. Protectivewasher 282 is thereafter snapped in place on IV pole 90 above supportclamp 276. With device clamp operating handle 270 rotated to its “A”position and device clamp end 268 retracted from space 264 device 70 isinstalled on pole 90 just above support assembly 286. Operating handle270 is thereafter rotated, in the clockwise direction about its pivot272, to project clamp end 268 against IV pole 90 to secure device 70 inplace on IV pole 90. It is proper procedure to check that device 70 issecured in place and so that IV pole 90 will not tip over and that thereis nothing obstructing air vents (not shown) provided bottom wall 104,or otherwise, of device 70. Reservoir holder 330 (FIGS. 2 & 8) isthereafter clamped onto IV pole 90 approximately 9″ above processingdevice 70 (FIG. 2).

Reservoirs 50, 52 are removed from disposable set 46, using aseptictechniques, by, disconnecting luer connectors 358 (FIG. 6) anddisconnecting fluid tubing 40 by pressing in the luer lock tab 360 andpulling out connector 358 and by disconnecting the thinner recirculationfluid line 40 by unscrewing its connector 358. Reservoirs 50, 52 whenremoved from disposable set 46 might best be placed on top of device 70but other convenient dispositions might be selected by the user.

With door 120 of device 70 (FIG. 3) open, heat exchanger rings 320(FIGS. 6 & 10) of disposable set 46 are placed around heater rings 142of heater 140. A red arrow (not shown) pointing up may be provided tofacilitate installing rings 320 on heater 140 and Red tinted tubing maybe utilized to correspond to a red stripe on device 70). Interlock block290 (FIGS. 3 & 11) should be firmly positioned into fluid out detector196. A section 350 (FIG. 11) of fluid line 60 (possibly blue tinted andcurved to facilitate installation) is guided over the pump head of pump160. Relatively thinner re-circulate fluid lines 352 (FIG. 6) extenddown from the bottom of each reservoir 50 and 52 to be joined togetherby a “Y” connector 62 and to extend there from as single re-circulateline 352 that is placed in a grove to the right of pump 160. The fluidlines should not be kinked or twisted to facilitate proper fluid flow.

Pressure chamber 230 (FIGS. 2, 6 & 12) is placed into pressure chamberwell 188 (FIG. 3) without applying excessive pressure or force thereto.A relative wide perfusion line 354 (FIG. 12), of disposable set 46, isthen firmly inserted into air detector 192 (FIGS. 3 & 12) and to theleft of diversion valve 194. A relatively thinner re-circulate fluidline 356 (FIG. 12), leading from pressure chamber 230, is position tothe right of air detector 192 and to the right of diversion valve 194.Access door 120 (FIGS. 2 & 3) of device 70 should then be closedinsuring that the fluid tubing is not caught thereby. Thereafter asection of fluid line, to be utilized for patient feed line 80 (FIGS. 1& 2) and return line 86 is connected to the infuse line luer lock. Thesection of patient feed/return fluid line is preferably 16 feet inlength but other lengths may be selected according to physician orders.

After reservoirs 50, 52 (FIG. 2) have been placed in reservoir receivers332, 334 respectively they are to be assembled back into disposable set46, using aseptic techniques. To the top of each of reservoirs 50, 52there should be re-attached: two fluid supply tails 362; one vacuumrelief valve 364; and a “Y” set for connecting a vacuum source 366 to anouter port 368 outside of a filter 370. To the bottom of each ofreservoirs 50, 52 there should be attached: one “Y” set for reservoiroutlet 372; one “Y” set for recirculation fluid line 374. Reservoiroutlet 372, and recirculation line 374, should also be connected to aluer 376 of disposable set 46 and reservoir holder 330 should beadjusted to make sure that the two connection leads underneathreservoirs 50, 52 are not stretched or kinked.

To provide a hyperthermia fluid lavage to a portion of the body ofpatient 84 the system power cord (not shown) should be connected into agrounded, 3-prong, 20 Amp, AC receptacle. The external temperatureinterface cables (not shown) should be plugged into device 70 at inputjacks 246,248 (FIG. 5). Turn power on by firmly pressing on/off switch292 (FIG. 2) to its “on” position. System 30, through its computer 146and associated operating hardware/software 148, will perform aself-check to check the integrity of system parameters. A cautionstatement such as “For Hyperthermic Treatment Only. Not for infusioninto the circulatory system” may appear on display 240. Press, “Agree”on display 240 and a “Password” screen may be displayed if a password isto be required. A factory default password, such as 111111 may beentered to set up system 30. Hang at least one 2-liter sterile fluid bag36, 38 (FIG. 2) on the IV pole 90. However, as many fluid bags asordered by a physician may be hug on IV pole 90. Preferably, fluid bags36, 38 are to provide physician ordered therapeutic fluid(s) such assterile normal saline, peritoneal dialysis solution, or othercrystalloid solution. The bag spike cap should be removed from the IVbag(s) and the fluid bag(s) should be fully pierced to ensure thatfluids flow freely. The ratchet clamp(s) for the respective piercedsolution(s) should be opened. Display 240 may show a PRIME screen. PressPRIME to recirculate 100 ml of fluid at 500 ml/min to remove air andfill the system with fluid. A priming volume, 100 ml, countdown maydisplayed on display 240. Pump 160 is set to stop automatically whencountdown reaches 0 ml. If priming has to be stopped, press STOP ondisplay 240 and the prime volume countdown will remain on the screen. Toresume priming system 30 Press RESUME PRIME on the display.

The section of patient line 88 to be utilized for the patient feed line80 and return line 86, as referred to herein above, should be given tosomeone in the “sterile field”, to be divided into patient feed line 80and return line 86 (with “Y” connection), and then returned from the“sterile field”. Also external temperature connections may be providedfrom the sterile field along with external temperature interface cables(not shown) to be there after connected to the device 70, white towhite. Push firmly to assure full contact. Forced mating of theconnectors can cause malfunction and interruption of electricalcontinuity. The external temperature probes (not shown), if needed, areplaced at patient locations selected by the physician. Such probes maybe Data scope 400 series disposable temperature probe with the whiteprobe connector P/N 0206-03-0118-02 or otherwise and are connected toinput jacks 246, 248 (FIG. 5) as described herein above. Return fluidline 86 (FIGS. 1 & 2) is connected to the luer lock of disposable set46. A directional arrow may be imprinted on the patient line. Onesection of return line 86 is connected to a respective one of reservoirs50, 52.

The patient in feed line 80 should be inspected to make certain that itis completely primed and free of air. This can be accomplished bypressing “PT. LINE PRIME” on display 240. System 30 will then prime at400 ml/min. An inspection should be made to make sure that no airremains in patient line 80. When air is no longer visible, “STOP” ondisplay 240 may be pressed. If there is, air bubbles after diversionvalve 194, press “PT. LINE PRIME” on display 240 again to remove air.The prescribed solution(s) should be dropped into reservoir(s) 50, 52either or both. As a caution, everyone involved may be informed that theprescribed solution(s) are ready to insure that only appropriatepersonnel are left in the room. “PERFUSE” on display 240, is thenpressed and pump 160 starts pumping at 10 ml/min. The “750 ML/MIN” ondisplay 240 should be pressed to operate pump 160 at 750 ml/min. Theflow rate may be adjusted, as needed, by pressing “RATE•RATE” on display240. The output temperature from heater 140 is adjusted from 37 degreesC. to 46 degrees C. by pressing “TARGET TEMP•/TARGET TEMP•” on display240 to reach the specified output temperature. The set temperature isdisplayed in both “TARGET TEMP” * and “TARGET TEMP* on display 240. Theactual fluid temperature, as it exits the heat exchanger rings 320,Tout, is also displayed on screen 240. Temperature isincreased/decreased by 0.5 degrees C. every time key is pressed.

The prescribed solution(s) 32, 34 are pumped as directed by the surgeon.The vacuum is adjusted to facilitate fluid return. The speed of pump 160should be regulated to keep the line pressure under the user-setpressure limit. Patient and system parameters should be checkedregularly on screen 240 and system alarms should be responded to whenand as needed. Additional sterile crystalloid or other solution IV bags36, 38 should be spiked, as needed, per the surgeon. System 30 providesfor a periodic beep when the pressure status line flashes and theperiodic beep sounds while the system is under pressure control. Linepressure is mainly due to the small orifice of the catheters or anyocclusions in the line. A pressure limit may be factory set to a maximumlimit of 300 mmHg. Such pressure limit may however be changed asrequired. System 30 is also programmed to automatically purges air fromthe system after every two liters of fluid has been pumped. A “RATE”status line displays “REMOVING AIR” during this process. The volumereadout (VOI) remains unchanged during automatic air purging and resumescounting when pumping resumes.

If there is fluid in the disposable set 46 when system 30 is not poweredon, patient line 80 should be clamped closed when opening door 120 ofdevice 70 to prevent uncontrolled fluid flow. If the flow rate is at orbelow 500 ml/min, the recirculation rate is temporarily set to 500ml/min during automatic air purging. If the flow rate is above 500ml/min, the recirculation rate is at the actual flow rate. When pumpingresumes, the system returns to the previously set flow rate. If on/offswitch 292 is not turned to STANDBY device, 70 will automatically switchto Battery Mode and will run until the battery is completely dischargedand shut down.

When the procedure is over pump 160 should be stopped and the ratchetclamp(s) on reservoir outlets should be clamped closed. The vacuumshould be increased, but not more than −150 mmHg, as needed, tofacilitate emptying the body cavity of patient 84. If total volumeexceeds 6 liters, an alternate source is required to empty the bodycavity In order to turn device 70 back to ON, turn on/off switch 292 toSTANDBY. Plug device 70 t in the AC outlet and wait approximately 20seconds before turning the power switch to ON. When all volume isreclaimed, clamp off patient line 80 and the bag spikes. Inflow, returnline, and external disposable temperature probes (if used) are handedoff the “sterile field” in orderly fashion and placed in a chemotherapybucket along with disposable set(s) 46 and all bags and attachments. Allshould be disposed according to the hospital policy. On/off switch 292should be moved to STANDBY.

In another embodiment of the instant invention reservoirs 50 and/or 52continue to function, as herein above described, as mixing andcontainment vessels and as thermal reservoirs. Pressure chamber 230(FIG. 6) still serves to provide fluid to patient fluid line 80 as wellas to re-circulate line 352 which includes a “Y” connector 62 throughwhich fluid is returned to the bottom of reservoirs 50 and 52 throughseparate sections of line 352 which each contain a check valve 308.[0013] Pressure chamber 230 has a number of functions, firstly operatingas a bubble trap whose function is accomplished by gravitationalseparation of air from fluid when diversion valve 194 (FIGS. 3 &12) isin an infuse position permitting fluid flow into patient infuse line 80.In that position of diversion valve 194 the recirculation line 352 isobstructed and patient line 80 is open. Fluid and any air present isforced into the chamber 230 (FIG. 6), by the peristaltic action of pump160, through the top of chamber 230 and such fluid only exits from thebottom of pressure chamber 230 where fluid then continues to the infuseline 80 and to the patient 84. Fluid line 40, when threaded over thepump head delivers fluids downstream peristaltic ally when roller pump160 is rotated. Heat exchanger rings 320 warm the fluid by convertingenergy generated by heater 140 by means of magnetic induction. Pressurechamber 230 secondly functions when diversion valve 194 (FIGS. 3 & 12)is in its re-circulate position (patient line 80 obstructed andre-circulate line 352 open), to return heated fluid to reservoirs 50 andor 52 and so that the peristaltic action of pump 160 will cause any aircollected at the top of the bubble trap in pressure chamber 230 to alsotravel back to reservoirs 50, 52. Pressure chamber 230 thirdlyfunctions, when a wall of pressure chamber 230 is in direct contact withpressure transducer 190 to provide feedback to computer 146 of theinternal pressure within the fluid path.

This inventive embodiment also consists of the provision of a means tostore heat energy within reservoirs 50 and/or 52 during off peak periodswhen there is relatively low fluid flow for use later when high fluidflow is required. To achieve this end input temperature probe 180measures the temperature of the infusate fluid and, if need be,appropriate action is taken, as by turning diversion valve 194 to itsre-circulate position. In that position the fluid is re-circulated frompressure chamber 230 through line 356 to and through reservoirs 50, 52,pump 160, heat exchange rings 320 and back to pressure chamber 230 toprewarm the fluid that is to be provided to patient 84. When temperatureprobe 180 indicates that the fluid is at a pre-selected temperatureaction, of device 70 may be turned off and/or diversion valve 194 turnedto its patient position. It is to be understood that this embodiment maybe applied either to hyperthermia lavage procedures or to infusing otherfluids by IV to patients' bloodstreams or for other medical procedures.It is to be also understood that the diversion valve 194 may beelectronically operated under computer control.

In yet another embodiment of the instant invention the second reservoirmay be used for the storage of packed red cells outside of therecirculation path for the purpose of minimizing the number of passesthrough peristaltic pump 160. In still a further embodiment of theinstant invention, an occlusive roller pump (not shown) whose operationis to act as a metering device replaces diversion valve 194. A patientfluid feed line is placed within this pump and a re-circulation line isallowed to flow freely. The main infusion would operate at a higher flowrate and the roller pump located at the diversion valve would meter flowto the patient. The algebraic difference between the two pumps would bereturned, heated, to the reservoir.

as various changes could be made in the above constructions withoutdeparting from the scope of the invention, it should be understood thatall matter contained in the above description and/or shown in theaccompanied drawing should be interpreted as illustrative and not in alimited sense.

What is claimed is:
 1. A process for performing partial bodyhyperthermia treatment comprising, (a) mounting a magnetic inductionheater upon an IV pole, wherein the magnetic induction heater comprisesan IV pole entry space of a size and configuration to receive the IVpole; (b) providing treatment fluid from a reservoir of a disposableset; (c) heating the treatment fluid, by the magnetic induction heater,to a temperature above a physiological temperature for a body to betreated; (d) causing fluid flow for the heated fluid, to a selectedportion of the body to be treated, and from that body portion; (e)causing the fluid to flow from the body portion to be treated in acontinuous enclosed path to where the fluid is heated and back to thebody portion to be treated, until the treatment is terminated; and (f)causing the fluid to flow at an operator set rate, wherein the mountingstep comprises positioning the magnetic induction heater such that theIV pole is received in the IV pole entry space and such that themagnetic induction heater is positioned on the IV pole above a base ofthe IV pole and below the reservoir.
 2. The process for partial bodyhyperthermia treatment of claim 1 further comprising, monitoring thefluid temperature and flow rate continuously.
 3. A system for performingpartial body hyperthermia treatment, the system comprising: anIV-pole-mountable magnetic induction heater for heating the treatmentfluid to a temperature above a physiological temperature for a body tobe treated; and a pump for: causing fluid flow for the heated fluid, toa selected portion of the body to be treated, and from that bodyportion; and causing the fluid to flow from the body portion to betreated in a continuous enclosed path to where the fluid is heated andback to the body portion to be treated, until the treatment isterminated; and a controller for regulating the temperature of theheated fluid and for causing the fluid to flow at an operator set rate,wherein the magnetic induction heater comprises an IV pole entry spaceof a size and configuration to receive a IV pole, and wherein themagnetic induction heater is positioned on the IV pole above a base ofthe IV pole.